The AE & SAE Reporting Landscape

Prior to the use of EDC, most data collection methods included complex paper-based forms. Coupled with the lack of communication and poor resources the process proved inefficient and time-consuming.

One of the barriers in AE reporting is the disconnect between the moment an AE occurs to its reporting. Especially when using outdated methods of data collection that do not allow for good communication between the involved parties.

However, with the widespread adoption of EDC and its continuous development, the MedTech industry stands to benefit. As EDC helps comply with regulations and maintain structured quality and safety reports for products on the market.

Why you should use the AE/SAE reporting module?

Traditional EDC solutions require the user to create an AE/SAE as a separate eCRF or form. In SMART-TRIAL you can use the AE/SAE module directly, which significantly reduces overall EDC setup time.

You eliminate duplicate documentation as all the data collected is stored in one location. Both investigator and sponsor have access to the AE/SAE report in real time which increases the productivity and communication.

A complete overview of the progress of individual reports, which benefits the users by reducing the workload and stress. Not having to search for paper-based reports, or checking on site-staff to get an overview of AE/SAE status saves time.

Semi-automated reporting. Based on the answers selected, only relevant fields will be shown or auto completed with subject information that’s available from within SMART-TRIAL. This helps to eliminate the human errors involved when using e.g. paper.

All changes/edits on the AE/SAE reports are recorded in Audit log

The benefits are without a doubt improvements to current paper-based standards.

How does the Adverse Events Module work?

In SMART-TRIAL there are three basic stages that all AE/SAE reports follow, i.e. Report, Classification, and Follow-Up.

AE flow

During reporting, a user creates a new AE/SAE report, which includes all of the basic information of the event. This is usually information that clarifies date of awareness, if it’s serious or normal AE, description of the event etc.

Classification is the clinical classification of the AE. This is usually carried out by a user that is authorized to classify AE/SAEs. During classification, a user has to confirm the clinical relevance of the event, such as the severity, actions taken, and relationship with IMP/IMD (investigational medical product/investigational medical device).

Follow-up is the last stage of every report, where a user has to complete the report, by following up with the subject on the potential outcome of the event. This usually includes information such as outcome results and end-date.

For a more detailed explanation of each step you can visit our help site

The SAE flow is slightly different from the standard AE flow. When reporting a Serious Adverse Event, the flow warrants for an additional level of action from a sponsor, i.e. Sponsor Initial Evaluation, and Sponsor final evaluation.

Sponsor initial evaluation is required after classification, and Sponsor final evaluation is required after follow-up. This includes the Sponsor’s evaluation of the event, and includes information such as; if the event was expected in relation to investigator’s Brochure/Summary of product characteristics, sponsor evaluation of the type of event, and evaluation of relation to IMP/IMD.

SAE Flow

In addition to being able to collect the standard AE/SAE information, you can also link events with concomitant medications from the SMART-TRIAL medication module. This provides an even better overview of subject’s progress in the study.

To see how the AE/SAE module looks and works in SMART-TRIAL, watch this video

Interoperability of EDC with AE/SAE reporting

Conclusively, when evaluating EDC solutions for clinical studies, one often forgets to evaluate the interoperability of the EDC with AE/SAE reporting.

But with SMART-TRIAL’s user-focused design, that makes full use of its EDC capabilities, you can increase data quality and overall efficiency of your AE/SAE reporting process, both for clinical studies and post-market surveillance.

The SMART-TRIAL AE/SAE module is available for all eCRF licenses that need to use its functionality. With a ready-to-use module, you not only minimise the setup time of your EDC, but you also gain added functionality which offers a more streamlined progress tracking of your AE/SAE reporting.

About The Author: Erika Pinto

Erika is SMART-TRIAL's leading market analyst and her focus is to share SMART-TRIAL's vision with MedTech and research organisations around the world. She has a Master's degree in Business Administration and IT from Copenhagen Business School.